Vertex: FDA Lifts Clinical Hold on Phase 1/2 Trial for Treatment of Type 1 Diabetes

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia. As a result, the Phase 1/2 trial will be reopened for screening, enrollment and dosing at multiple sites in the U.S.

To date, three patients have been dosed in the Phase 1/2 study with VX-880. Two patients received half the target dose of cells in Part A of the study. A third patient has received the full target dose in Part B of the study. Part B will evaluate safety and efficacy in five patients at the target dose before expanding to additional patients in Part C.

https://www.biospace.com/article/releases/vertex-announces-fda-has-lifted-the-clinical-hold-on-vx-880-phase-1-2-clinical-trial-for-the-treatment-of-type-1-diabetes/